ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease

Not Applicable

Completed

Conditions: Parkinson's Disease

Interventions: Device: ExAblate Transcranial MRgFUS
Device: Sham ExAblate Transcranial MRgFUS

Registration Number: NCT01772693

Lead Sponsor: InSightec

Brief Summary: This is a feasibility study to evaluate the safety and initial effectiveness of unilateral ExAblate thermal ablation of the Vim thalamic nucleus of subjects suffering from medication-refractory, idiopathic, tremor-dominant PD, using the ExAblate Transcranial system compared to a Sham Vim thalamotomy procedure.

Data will be collected to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy. The Sham treatment data will be used to evaluate placebo effect from treatment.

Detailed Description: Subjects who sign informed consent and pass all eligibility criteria will be randomized to a treatment assignment. During treatment, the assigned treatment (ExAblate Transcranial or Sham ExAblate Transcranial)will be delivered. Subjects are followed in a blinded fashion for three (3) months. After the 3-month assessment, subjects will be unblinded and told their treatment assignment. Subjects receiving Sham ExAblate Transcranial treatment who still meet criteria will be crossed over and receive an active ExAblate Transcranial treatment. Subjects will be followed for up to two (2) years. Follow-up at 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and up to two (2) years includes Unified Parkinson's Disease Rating Scale (UPDRS) scoring, mental and cognitive functional testing and questionnaires.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

Inclusion Criteria

Men and women, age 30 years and older
Subjects who are able and willing to give informed consent and able to attend all study visits
Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
Subject exhibits a significant disability from their PD tremor despite medical treatment
Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
Subject is able to communicate sensations during the ExAblate Transcranial procedure

Exclusion Criteria

Subjects with unstable cardiac status
Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
Severe hypertension
Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
Significant claustrophobia that cannot be managed with mild medication
Current medical condition resulting in abnormal bleeding and/or coagulopathy
Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
History of intracranial hemorrhage
History of multiple strokes, or a stroke within past 6 months
Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
Are participating or have participated in another clinical trial in the last 30 days
Subjects unable to communicate with the investigator and staff
Subjects with a history of seizures within the past year
Subjects with brain tumors
Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ExAblate Transcranial MRgFUS	ExAblate Transcranial MRgFUS	ExAblate Transcranial MR guided Focused Ultrasound
Sham ExAblate Transcranial MRgFUS	Sham ExAblate Transcranial MRgFUS	Sham treatment with ExAblate MR guided Focused Ultrasound

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Month 3	Evaluate of adverse events (AEs) associated with the ExAblate Transcranial thalamotomy of medication-refractory, tremor-dominant PD during the ExAblate treatment. Primary safety analyses are reported in the adverse events module.

Secondary Outcome Measures

Name	Time	Method
Tremor Motor Score Percent Change From Baseline.	Baseline, Month 3	The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).
Tremor Motor Scores - Clinical Rating Scale for Tremor - Treated Side Upper Extremity Parts A & B.	Baseline, Month 3, Month 12	Upper extremity Tremor-Motor score for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that measures treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points for each side with lower scores being a better outcome. Subject's Tremor-Motor scores for the test and sham control groups were averaged at each study visit.
Functional Disabilities - Clinical Rating Scale for Tremor Part C - Functional Disabilities	Baseline, Month 3, Month 12	The Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores.